Cushioned on the way up, controlled on the way down during resuscitative endovascular balloon occlusion of the aorta (REBOA): investigating a novel compliant balloon design for optimizing safe overinflation combined with partial REBOA ability.

Background: There are a variety of devices capable of performing resuscitative endovascular balloon occlusion of the aorta (REBOA), with most containing compliant balloon material. While compliant material is ideal for balloon inflation due to its "cushioning" effect, it can be problematic to "control" during deflation. The COBRA-OS (Control Of Bleeding, Resuscitation, Arterial Occlusion System) was designed to optimize inflation and deflation of its compliant balloon and was tested in vitro and in vivo with respect to its overinflation and partial REBOA abilities. Methods: For overinflation, the COBRA-OS was inflated in three differently sized inner diameter (ID) vinyl tubes until balloon rupture. It was then overinflated in six harvested swine aortas and in all three REBOA zones of three anesthetized swine. For partial REBOA, the COBRA-OS underwent incremental deflation in a pulsatile benchtop aortic model and in zone 1 of three anesthetized swine. Results: For overinflation, compared with the known aortic rupture threshold of 4 atm, the COBRA-OS exceeded this value in only the smallest of the vinyl tubes: 8 mm ID tube, 6.5 atm; 9.5 mm ID tube, 3.5 atm; 13 mm ID tube, 1.5 atm. It also demonstrated greater than 500% overinflation ability without aortic damage in vitro and caused no aortic damage when inflated to maximum inflation volume in vivo. For partial REBOA, the COBRA-OS was able to provide a titration window of between 3 mL and 4 mL in both the pulsatile vascular model (3.4±0.12 mL) and anesthetized swine (3.8±0.35 mL). Discussion: The COBRA-OS demonstrated the ability to have a cushioning effect during inflation combined with titration control on deflation in vitro and in vivo. This study suggests that despite its balloon compliance, both safe overinflation and partial REBOA can be successfully achieved with the COBRA-OS. Level of evidence: Basic science.

Size matters: first-in-human study of a novel 4 French REBOA device.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an emerging technique used for non-compressible torso hemorrhage. However, its current use continues to be limited and there is a need for a simple, fast, and low profile REBOA device. Our objective was to evaluate the feasibility of a novel 4 French REBOA device called the COBRA-OS (Control of Bleeding, Resuscitation, Arterial Occlusion System). METHODS: This study is the first-in-human feasibility trial of the COBRA-OS. Due to the difficulty of trialing the device in the trauma setting, we performed a feasibility study using organ donors (due to the potential usefulness of the COBRA-OS for normothermic regional perfusion) after neurological determination of death (NDD) prior to organ retrieval. Bilateral 4 French introducer sheaths were placed in both femoral arteries and the COBRA-OS was advanced up the right side and deployed in the thoracic aorta (Zone 1). Once aortic occlusion was confirmed via the left-sided arterial line, the device was deflated, moved to the infrarenal aorta (Zone 3), and redeployed. RESULTS: A total of 7 NDD organ donors were entered into the study, 71% men, with a mean age 46.6 years (range 26 to 64). The COBRA-OS was able to occlude the aorta in Zones 1 and 3 in all patients. The mean time of placing a 4 French sheath was 47.7 seconds (n=13, range 28 to 66 seconds). The mean time from skin to Zone 1 aortic occlusion was 70.1 seconds (range 58 to 105 seconds); mean balloon volumes were 15 mL for Zone 1 (range 13 to 20 mL) and 9 mL for Zone 3 (range 6 to 15 mL); there were no complications and visual inspection of the aorta in all patients revealed no injury. DISCUSSION: The COBRA-OS is a novel 4 French REBOA device that has demonstrated fast and safe aortic occlusion in this first-in-human feasibility study. LEVEL OF EVIDENCE: Level V, therapeutic.

Health indicators, social support, and intimate partner violence among women utilizing services at a community organization.

PURPOSE: Intimate partner violence (IPV) against women is a significant public health concern. This study examines the physical and mental health status and relationship to social support for women seeking services to end IPV at a walk-in community organization that serves the community at large, including a shelter for abused women. METHODS: One hundred seventeen (117) English-speaking women between the ages of 18 and 61 years participated in a self-administered survey. Physical, mental, and oral health, social support, and IPV homicide lethality were measured using standardized instruments. RESULTS: Social support was the most important factor related to better health. The participants who had more social support reported better physical (p < .05), mental (p < .01), and oral health (p < .05), and a lower level of psychological distress (p < .01) and depression (p < .01) compared with participants who reported less social support. The participants living in the shelter reported worse physical health (p < .05) but better mental health (p < .05) than the participants not living in a shelter. Older age and low income were related to oral health problems, whereas older age, low education level, and unemployment were related to poor mental health. CONCLUSION: The present study adds to the evidence that social support contributes to improving physical and mental health for women who experience IPV. The findings also suggest the importance of providing or referring women to mental health services.

Court compliance as a predictor of postadjudication recidivism for domestic violence offenders.

This study evaluated pre- and postadjudication behavior of 220 male defendants convicted of a domestic violence-related offense using court records and police department data. Our goal was the identification of possible predictors for continued criminal behavior that could pose a risk of further harm to victims. Factors identified as significant predictors of defendant recidivism were having two or more court reports of noncompliance with domestic violence treatment, two or more warrants issued by the court for noncompliance, and two or more reports to law enforcement of new criminal activity involving the defendant. Law enforcement reports were the strongest predictor of recidivism, with an odds ratio of 7.7 and confidence interval of 3.0-19.7. These results illustrate the importance of monitoring multiple dimensions of defendant behavior while under court supervision and of communicating information on noncompliance with victims and advocates to assist in safety planning efforts.

Outcomes of civil protective orders: results from one state.

This study compares final sentencing decisions ordered by judges to federal and state sentencing guidelines for protective order violations. The authors reviewed violations that were pled before the largest district court in Utah and found that in the majority of cases, defendants were not sentenced in accordance with federal and state guidelines. Although state guidelines mandate defendants who violate a protective order to attend a batterer intervention program, less than one fourth of defendants were sentenced to attend such programs. Fewer than half of the defendants were arrested and incarcerated, as opposed to the 100% mandated by state sentencing guidelines. Federal guidelines mandate that all defendants be ordered to surrender firearms, but only six defendants were given that order. This study shows that the judicial system could be more aggressive in improving the safety of victims of intimate partner violence by using the full extent of the sentencing guidelines.